Russia’s sovereign wealth fund on Wednesday said it had reached an agreement with Indian pharmaceuticals major Dr Reddy’s Laboratories to cooperate on clinical trials and distribution of the Sputnik V vaccine for Covid-19 in India.
“Upon regulatory approval in India, the RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine,” the Russian Direct Investment Fund (RDIF) said in a statement.
“The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the Coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India,” the statement added.
Russia’s envoy to India, Nikolay Kudashev, has held discussions with Indian officials in recent weeks on cooperation in the development of a vaccine, including joint development and production of Sputnik V.
The Russian side also formally shared modalities for cooperation on the vaccine with Indian authorities which are yet to take a call on the matter, people familiar with developments said on condition of anonymity.
The vaccine is also believed to have figured in discussions held during external affairs minister S Jaishankar’s visit to Moscow last week for a meeting of the foreign ministers of the Shanghai Cooperation Organisation (SCO) states.
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RDIF said its agreement with Dr Reddy’s “reflects the growing awareness of countries and organisations to have a diversified anti-Covid vaccine portfolio to protect their populations”.
The CEO of RDIF, Kirill Dmitriev, said, “We are very pleased to partner with Dr Reddy’s in India. Dr Reddy’s has had a very well-established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India”.
“India is amongst [the] most severely impacted countries from Covid-19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against Covid-19,” he added.
Dmitriev said the RDIF’s partners will receive an “effective and safe drug” and the platform of human adenoviral vectors, which forms the core of the Russian vaccine, has been “tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences”.
GV Prasad, co-chairman and managing director of Dr Reddy’s, said the phase I and phase II results “have shown promise, and we will be conducting phase III trials in India to meet the requirements of the Indian regulators”.
Russia’s health ministry registered the Sputnik V vaccine developed by Gamaleya National Research Institute of Epidemiology and Microbiology on August 11. A research paper on the results of phase I and phase II clinical trials of Sputnik V published in The Lancet, a leading international medical journal, on September 4 said it had demonstrated no serious adverse effects and a stable immune response in 100 percent of participants.
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Post-registration clinical trials of Sputnik V, involving 40,000 volunteers, are currently ongoing, the RDIF said. More than 55,000 volunteers applied to join the post-registration trials and the first results of these trials are expected to be published in October-November, it added.
The Serum Institute of India is also working with Oxford University and AstraZeneca on another Covid-19 vaccine.